- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076412
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP) (FIT)
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Rankweil, Austria, 6830
- LKH Feldkirch at LKH Rankweil
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AU
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Vienna, AU, Austria, 1140
- Hanusch-Krankenhaus Wiener Gebietskrankenkasse
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Wien, AU, Austria, 1090
- Medizinische Universitaet Wien / AKH Wien
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Pleven, Bulgaria, 5800
- UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
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Sofia, Bulgaria, 1431
- UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology
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BG
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Sofia, BG, Bulgaria, 1756
- Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
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Vratsa, BG, Bulgaria, 3000
- MHAT Hristo Botev, AD, Vratsa, First Internal Department
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Ostrava-Poruba, Czechia, 708 52
- Fakultni nemocnice Ostrava
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Praha 10, Czechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Praha 2, Czechia, 128 08
- Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie
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CZ
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Brno, CZ, Czechia, 625 00
- Fakultni nemocnice Brno
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Kyjov, CZ, Czechia, 69733
- Hospital Kyjov
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Berlin, Germany, 12203
- Charit Berlin - Campus Benjamin Franklin
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Duesseldorf, Germany, 40479
- Marien Hospital Duesseldorf
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Essen, Germany, 45147
- Universittsklinikum Essen
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DE
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Giessen, DE, Germany, 35392
- Universitaetsklinikum Giessen und Marburg (UKGM)
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Hannover, DE, Germany, 30159
- Werlhof Institut GmbH
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Bergen, Norway, 5021
- Haukeland University Hospital
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Fredrikstad, Norway, 1606
- Sykehuset Østfold Fredrikstad
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Gdansk, Poland, 80-952
- Uniwersyteckie Centrum Kliniczne
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Krakow, Poland, 31-501
- Szpital Uniwersytecki
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Lodz, Poland, 93-510
- Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
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Lublin, Poland, 20-081
- Specjalistyczny Gabinet Lekarski
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Opole, Poland, 45-064
- Szpital Wojewodzki w Opolu
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Slupsk, Poland, 76-200
- Wojewodzki Szpital Specjalistyczny im. J. Korczaka
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Warszawa, Poland, 02-776
- Instytut Hematologii i Transfuzjologii
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Wroclaw, Poland, 50-367
- Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
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Bucuresti, Romania, 020125
- Spitalul Clinic Colentina, Hematologie
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Bucuresti, Romania, 030171
- Spitalul Clinic Coltea, Hematologie
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Mures
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Targu Mures, Mures, Romania, 540136
- Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
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Madrid, Spain, 28046
- Hospital Universitariola Paz
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Valencia, Spain, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
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New York
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Nyack, New York, United States, 10960
- Hematology Oncology Associates of Rockland Division of Highland Medical PC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of persistent/chronic ITP for at least 3 months
- Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts
Exclusion Criteria:
- Clinical diagnosis of autoimmune hemolytic anemia
- Uncontrolled or poorly controlled hypertension
- History of coagulopathy including prothrombotic conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
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Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Other Names:
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OTHER: Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
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Placebo tablet PO bid (morning and evening)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Stable Platelet Response of at Least 50,000/µL
Time Frame: Baseline to Week 24
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Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24
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Baseline to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
Time Frame: Baseline to Week 12
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Platelet Count ≥ 50,000/µL at Week 12
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Baseline to Week 12
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Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
Time Frame: Baseline to Week 24
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Platelet Count ≥ 50,000/µL at Week 24
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Baseline to Week 24
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Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12
Time Frame: Baseline to Week 12
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Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 12.
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Baseline to Week 12
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Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24
Time Frame: Baseline to Week 24
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Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 24
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Baseline to Week 24
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Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)
Time Frame: Baseline to Week 24
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The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data. The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. |
Baseline to Week 24
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Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale
Time Frame: Baseline to Week 24
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The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data. The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. |
Baseline to Week 24
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- C-935788-048
- 2013-005453-76 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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